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" Development and approval of combination products : "


Document Type : BL
Record Number : 656810
Doc. No : dltt
Title & Author : Development and approval of combination products : : a regulatory perspective /\ edited by Evan B. Siegel
Publication Statement : Hoboken, N.J. :: Wiley,, c2008
Page. NO : xii, 215 p. :: ill. ;; 25 cm
ISBN : 9780470050941 (hbk.)
: : 0470050942 (hbk.)
Bibliographies/Indexes : Includes bibliographical references and index
Contents : Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier
Subject : United States.
Subject : Drug approval-- United States
Subject : Biological products-- United States
Subject : Medical instruments and apparatus-- United States
Subject : Drug Approval-- legislation jurisprudence
Subject : Drug Combinations
Subject : Device Approval-- legislation jurisprudence
Subject : United States
LC Classification : ‭RA401.5‬‭.D48 2008‬
: ‭RA401.5‬‭.D48 2008‬
Added Entry : Siegel, Evan B
copyhttps://lib.clisel.com/site/catalogue/656810
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